Kindeva Drug Delivery
Supervisor, Production Operations
Kindeva Drug Delivery, Saint Louis, Missouri, United States, 63146
Overview
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The production operations supervisor provides supervision of aseptic filling, sterile sub-assembly operations and (union) operators. This individual is responsible for the aseptic filling of all products and assuring processes are performed in compliance with cGMPs and following Standard Operating Procedures (SOPs). Role Responsibilities
Instructs the filling and subassembly operations of (union) operators in the daily duties and assures they are performed in a timely manner and in conformance with cGMP. Supervises operations to ensure adherence with all Safety requirements. Immediately addresses all safety events or concerns with Environmental, Health and Safety (EHS) personnel. Performs GMP audits of the aseptic processing area as required and investigates any process deviations; perform daily reviews of area batch records for accuracy and ensures compliance with Standard Operating Procedures and adherence to aseptic processing requirements. Composes new or revises departmental SOPs as required. Reports any significant shift activities to the Manager; root cause analysis and ability to define effective corrective/preventative action. Coordinates personnel activities—vacations, sick time, etc.—to ensure there is appropriate coverage in the department at all times; addresses personnel issues as they arise; trains new operators; conducts reviews with operators. Maintains inventory on materials and sterile items used in the aseptic processing area. Maintains and improves labor standards. Assist with development and maintenance of the annual department overhead budget and orders supplies for area. Schedule shift to maintain hands-on support with operators; fill in for other supervisors as needed. Maintain communications with MRCs for batch records and SOPs; coordinate equipment maintenance and repairs with the Tech services group; coordinate with QC Lab for laboratory testing; coordinate with materials and Planning for scheduling of filling operations and ordering of materials; report daily activities to Manager/TL and receive information on activities for the area; coordinate with MQA for any quality issues/concerns. Aseptic Quality Coaching – continuously observe and review aseptic practices on the manufacturing floor as applicable to each manufacturing suite. Basic Qualifications
HS Diploma 3+ years previous supervisory experience required and/or combination of education and experience Preferred Qualifications
Associates or Bachelor’s degree in Engineering, Chemistry, Computer Science or other Technology or Life Science field Pharmaceutical or manufacturing experience Site California residents should review our Notice for California Employees and Applicants before applying. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral. Equal Opportunity Employer
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
#J-18808-Ljbffr
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The production operations supervisor provides supervision of aseptic filling, sterile sub-assembly operations and (union) operators. This individual is responsible for the aseptic filling of all products and assuring processes are performed in compliance with cGMPs and following Standard Operating Procedures (SOPs). Role Responsibilities
Instructs the filling and subassembly operations of (union) operators in the daily duties and assures they are performed in a timely manner and in conformance with cGMP. Supervises operations to ensure adherence with all Safety requirements. Immediately addresses all safety events or concerns with Environmental, Health and Safety (EHS) personnel. Performs GMP audits of the aseptic processing area as required and investigates any process deviations; perform daily reviews of area batch records for accuracy and ensures compliance with Standard Operating Procedures and adherence to aseptic processing requirements. Composes new or revises departmental SOPs as required. Reports any significant shift activities to the Manager; root cause analysis and ability to define effective corrective/preventative action. Coordinates personnel activities—vacations, sick time, etc.—to ensure there is appropriate coverage in the department at all times; addresses personnel issues as they arise; trains new operators; conducts reviews with operators. Maintains inventory on materials and sterile items used in the aseptic processing area. Maintains and improves labor standards. Assist with development and maintenance of the annual department overhead budget and orders supplies for area. Schedule shift to maintain hands-on support with operators; fill in for other supervisors as needed. Maintain communications with MRCs for batch records and SOPs; coordinate equipment maintenance and repairs with the Tech services group; coordinate with QC Lab for laboratory testing; coordinate with materials and Planning for scheduling of filling operations and ordering of materials; report daily activities to Manager/TL and receive information on activities for the area; coordinate with MQA for any quality issues/concerns. Aseptic Quality Coaching – continuously observe and review aseptic practices on the manufacturing floor as applicable to each manufacturing suite. Basic Qualifications
HS Diploma 3+ years previous supervisory experience required and/or combination of education and experience Preferred Qualifications
Associates or Bachelor’s degree in Engineering, Chemistry, Computer Science or other Technology or Life Science field Pharmaceutical or manufacturing experience Site California residents should review our Notice for California Employees and Applicants before applying. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral. Equal Opportunity Employer
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Do you see yourself as part of the Kindeva mission? Click Apply Now Today!
#J-18808-Ljbffr